Sublingual and buccal film compositions
AssigneeMonosol Rx, LLC
InventorsGarry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, Madhusudan Hariharan
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Abstract
The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.
Claims30
Self-supporting, individual film dosage units each containing an agonist and an antagonist, each individual unit comprising:
- (a) about 30 wt % to about 70 wt % of a water-soluble polymeric matrix comprising one or more polyethylene oxide polymers;
- and a polymer selected from the group consisting of cellulose, a cellulose derivative, polyvinylpyrrolidone (PVP), polyvinylalcohol (PVA), polysaccharides and combinations thereof;
- (b) an agonist or a pharmaceutically acceptable salt thereof;
- (c) an antagonist or a pharmaceutically acceptable salt thereof;
- and
- (d) a component selected from the group consisting of citral, alphacitral, neral, decanal, a C8 aldehyde, a C9 aldehyde, a C12 aldehyde and combinations thereof;
- wherein:
- (i) the pKa ratio of agonist:antagonist in the individual dosage units is from about 5.0:9.0 to about 9.5:6.0;
- (ii) the weight ratio of agonist:antagonist in the oral film is about 6:1 to about 2:1;
- and
- (iii) the weight ration of agonist:buffer in the oral film is about 2:1 to about 1:5.
The individual film dosage units of 4, wherein the sugar alcohol is selected from the group consisting of maltitol, sorbitol, mannitol, xylitol and combinations thereof.
Self-supporting, individual film dosage units each containing an agonist and an antagonist, said individual film dosage units comprising:
- (a) about 30 wt % to about 70 wt % of a water-soluble polymeric matrix comprising one or more polyethylene oxide polymers;
- and a polymer selected from the group consisting of cellulose, a cellulose derivative, polyvinylpyrrolidone (PVP), polyvinylalcohol (PVA), a polysaccharide and combinations thereof;
- (b) an agonist or a pharmaceutically acceptable salt thereof;
- (c) an antagonist or a pharmaceutically acceptable salt thereof;
- (d) maltitol;
- (e) a component selected from the group consisting of citral, alphacitral, neral, decanal, a C8 aldehyde, a C9 aldehyde, and a C12 aldehyde,
- (f) acesulfame K;
- (g) a color;
- and
- (h) sodium citrate;
- wherein;
- (i) the pKa ratio of agonist:antagonist in the individual dosage units is from about 5.0:9.0 to about 9.5:6.0;
- (ii) the weight ratio of agonist:antagonist in the oral film is about 6:1 to about 2:1;
- and
- (iii) the weight ratio of agonist:buffer in the oral film is about 2:1 to 1:5.
Dependencies are inferred from the claim text.